HKK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Telescope, Spectacle, Low-Vision
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5870
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 (K870203) | Keeler Instruments, Inc. | 1987-02-12 | + Add |
| DUALENZ LOW VISION EYEWEAR (K864594) | Global Eye Care, Inc. | 1987-01-20 | + Add |
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